Associate Director, Patient-Centered Outcomes Research (Oncology)

Role Summary

Associate Director, Patient-Centered Outcomes Research (Oncology) responsible for designing and executing strategically-focused patient experience data (PED) evidence to optimize product registration, access & reimbursement, and clinical practice. Supports multiple programs across therapeutic areas and collaborates cross-functionally with HEOR Strategy, Clinical Development and Operations, Regulatory, and Commercial, as well as external partners. Serves as SME on PED and patient-centered measurement strategies to drive adoption of standards and best practices.

Responsibilities

• Responsible for execution of global PED evidence generation and stakeholder engagement strategies across multiple therapeutic areas in alignment with asset strategy
• Leads management of projects to ensure timely PED research that characterizes patient outcomes, identifies patient preferences and unmet needs, informs patient-focused measurement strategies, and develops innovative patient-relevant outcomes measures
• Supports alignment of strategy with HEOR-Strategy and translates results to cross-functional teams to integrate PED plans into broader evidence plans
• Ensures scientific quality and integrity of COA research via development of proposals, protocols, analysis plans and reports
• Leads integration of COA measurement strategy into clinical development programs, including protocol/SAP content development, results interpretation, CSR development, and COA implementation on eCOA platforms
• Leads development, validation, and implementation of COA measures for RCTs and observational studies
• Contributes to regulatory and reimbursement submission strategy and participates in discussions/negotiations to optimize registration, labeling, promotion, and patient access decisions
• Develops strategic scientific communication plans including submissions and presentations in peer-reviewed journals and at congresses
• Acts as internal SME to identify new methodologies and advancements in COA methods and regulatory requirements
• Develops and delivers standards, best practices, and educational resources to drive patient voice integration across AbbVie

Qualifications

• Advanced degree in Psychology, Epidemiology, Statistics, Public Health, Health Economics and Outcomes Research (HEOR) or related discipline (MS, MPH, PharmD, PhD) preferred
• Minimum of 5 years of experience in pharmaceutical/consulting with PED research, clinical outcome assessment, psychometric validation, and medical product development
• Demonstrated ability to develop PED from conceptualization through global negotiations
• Experience in regulatory & HTA submissions
• Excellent interpersonal, written, and verbal communication skills; ability to influence across internal and external stakeholders
• Strong ability to manage multiple priorities in a dynamic environment
• Experience delivering services across complex matrix/global environments; strong project management
• Knowledge of regulatory/compliance frameworks and clinical trial design; knowledge of regulatory & HTA requirements for patient-centered endpoints
• Ability to interpret and communicate research results to diverse audiences and collaborate with HEOR capabilities
• Travel up to 15%

Skills

• COA/PRO development and validation
• Clinical trial design and CSR development
• Regulatory and HTA submission preparation
• Strategic planning and cross-functional collaboration
• Data interpretation and scientific communication
• Project management and vendor management

Education

• Advanced degree as listed in Qualifications

Additional Requirements

• Travel ‚Äì up to 15% travel